The effectiveness of pharmacological treatment with the glucagon-like peptide-1 receptor agonist Liraglutide 3mg (Saxenda®) once-daily for weight management in forensic psychiatry; An Exploratory pilot study.

Mental Health Center Copenhagen0 个研究点目标入组 40 人开始时间: 2020年8月30日最近更新: 2022年3月2日

试验速览

暂无简介。

•1.Informed oral and written consent
•2.Diagnosed with a mental illness
•3.Hospitalised at a forensic psychiatric department
•4.Age 18 years to 65 years (both included)
•5.BMI =27 kg/m2 with one or more weight-related comorbidities (hypertension, dyslipidaemia, pre-diabetes or type 2 diabetes) or BMI =30 kg/m2
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 38
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.Any use of coercive measures according to the Danish law for Mental Health/Psykiatriloven (as defined in Informationsbekendtgørelsen § 10”).
•2.Fertile females of child-bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant
•3.Women who are not willing to use adequate contraceptive during the full length of the study
•4.Impaired hepatic function (plasma liver transaminases >2 times the upper normal limit)
•5.Impaired renal function (serum creatinine >150 µmol/l and/or macroalbuminuria)
•6.Impaired pancreatic function (acute or chronic pancreatitis and/or plasma amylase >2 times the upper normal limit)
•7.Cardiac problems defined as decompensated heart failure (NYHA class III/IV), unstable angina pectoris and/or myocardial infarction within the last 12 months
•8.Hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >100 mmHg
•9.Any condition that the investigator feels would interfere with trial participation
•10.Use of weight-lowering pharmacotherapy within the preceding 3 months
•11.Type 1 diabetes.
•12.Patients treated with insulin
•13.Patients treated with other GLP-1 receptor agonist medicines
•14.Known allergy to liraglutide or any of the ingredients in Saxenda

发起方

Mental Health Center Copenhagen